Regulatory Affairs Specialist II – Structural Heart (on-site)

Abbott • Saint Paul, MN

12d • Onsite

About The Position

Abbott is recruiting an on-site Regulatory Affairs Specialist II for its Structural Heart team in New Brighton, Minnesota. This individual-contributor role supports the regulatory department in maintaining efficient, compliant business processes and may assist with worldwide product registrations by preparing and submitting documentation, with a strong focus on post-market change management. The role involves exercising judgment within established practices and influencing work generally at the middle-management level.

The specialist analyzes cumulative product changes to current submissions, supports regulatory strategies and change-control decisions, and follows submission activities through to product approval. The role also includes preparing clear written communications for external regulatory agencies, routine negotiations with government agencies on product-related issues, supporting compliance issue resolution, following GMP guidelines, and implementing and maintaining the effectiveness of the quality system. Submission documents require supervisory regulatory review before they are sent to government agencies.

Requirements

• Bachelor’s degree or an equivalent combination of education and work experience.
• 2–3 years of experience in a regulated industry, such as medical products or nutritionals; higher education may compensate for years of experience.
• Ability to work in a team and complete projects in a fast-paced, matrixed environment.
• Strong verbal and written communication skills, with the ability to communicate effectively at multiple organizational levels.
• Ability to exercise judgment within generally defined practices and policies when selecting methods and techniques to obtain solutions.
• Sound knowledge of alternatives and their impact on the business.
• Ability to apply business and regulatory ethical standards.

Nice To Haves

• Regulatory Affairs experience; experience in quality assurance, research and development/support, scientific affairs, operations, or a related area may also be considered.
• Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, or pharmacology), mathematics, engineering, or a medical field.
• Certification such as RAC from the Regulatory Affairs Professionals Society.
• Analytical thinking and good problem-solving skills.

Responsibilities

• Analyze the input of cumulative product changes to current product submissions.
• Share knowledge with colleagues in the department and on cross-functional teams.
• Establish and execute project goals and implement plans; provide input to group plans and their implementation.
• Follow GMP guidelines and procedures.
• Prepare clear, concise written information for varying audiences, particularly external regulatory agencies.
• Implement and maintain the effectiveness of the quality system.
• Advise project, group, or venture teams on basic regulatory strategies.
• Sign off at team level within delegated parameters for change control.
• Provide release authority for labeling, sales, and promotional materials.
• Conduct basic negotiations with government agencies on routine product-related issues.
• Follow through on submission-related activities to secure product approval.
• Direct daily activities in alignment with team goals and division regulatory priorities.
• Support Regulatory Affairs management in resolving compliance issues in accordance with site and division policies, procedures, and quality-system requirements.
• Obtain supervisory regulatory review of submission documents before submission to government agencies.

Benefits

• Career development opportunities with an international company.
• Potential eligibility for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, an affordable and convenient path to earning a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level